The proper production of safe and effective prescription drugs is central to a number of important regulatory and public policy issues now in the spotlight. The White House is orchestrating a campaign to reduce abuse and misuse of prescription drugs, with a focus on extended-release opioids. The spread of adulterated drugs across the globe is prompting initiatives to curb violative imports. At the same time, patient groups and physicians are anxious to resolve shortages of important therapies and ensure access to needed medicines. FDA is a prominent player in the crackdown on opioid abuse and oversight of drug imports, and is also keeping an eye on possible disruptions in supplies for patients. These developments add to pressure on manufacturers to secure supply chains, comply with GMPs, and to develop products that resist tampering and abuse.

SHORTAGES LIMIT ACCESS

From high-security prisons to cancer clinics, crucial drug shortages are placing attention on drug manufacturing and supply issues. Disruptions in access to life-saving chemotherapies, anesthetics, and pain medications have made headlines, along with difficulties for law enforcement officials seeking approved drugs for lethal injection. Many of the shortages involve generic sterile injectibles that have been hit by a number of problems: industry consolidation that reduces competitive production, limited supplies of active ingredients, and manufacturing difficulties that have led to plant closures. Generic-drug manufacturer Teva, for example, had to shut down a California injectable drug facility after an FDA inspection cited numerous GMP violations. Compounding the difficulties is the increased import of active ingredients from foreign suppliers, China in particular.

A March 2011 survey by the Premiere Healthcare Alliance found that last year, more than 240 drugs were either in short supply or unavailable in the US. Efforts to obtain alternative therapies boosted hospital and provider costs by at least $200 million. Even worse, shifts to different medicines appear to boost medication errors as practitioners make mistakes mixing and administering less familiar products.

In response, FDA has moved to approve the import of cancer and leukemia therapies produced overseas. The agency also has authorized prison officials to import sodium thiopental from unapproved foreign producers, a move that generated lawsuits arguing a lack of evidence for potency and efficacy of the imported drug, along with opposition from foreign governments opposed to using their products for capital punishment.

The situation has prompted calls to bolster FDA authority to require advance notice from more manufacturers about plans to discontinue production of short-supply drugs. The agency has fairly limited notification authority and often receives scant information from manufacturers on factors causing new shortages. Pharmaceutical companies generally oppose long advance notification requirements, noting that supply changes often cannot be predicted far in advance, and that manufacturing problems usually occur without warning.